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A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations

ConditionAdvanced Solid Tumors With MAPK Pathway Mutations
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorD3 Bio (Wuxi) Co., Ltd

About this trial

This first-in-human (FIH) study aims to assess the safety, tolerability, pharmacokinetics, and recommended phase 2 dose (RP2D) of D3S-002 given orally daily for 21-day cycles in adult subjects with advanced solid tumors with mitogen-activated protein kinase (MAPK) pathway mutations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Part 1: Subjects must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor with evidence of progressive disease.

Part 2: Subjects must have a histologically or cytologically confirmed metastatic or locally advanced non-small cell lung cancer with evidence of PD.

Subjects with non-small cell lung cancer (NSCLC) should have no known epidermal growth factor receptor (EGFR) mutations, ALK/ROS1/RET rearrangements, NTRK1/2/3 gene fusions, v-Raf murine sarcoma viral oncogene homolog B (BRAF) V600E mutations, or MET exon 14 skipping mutations.

Part1: Subjects must have documented mitogen-activated protein kinase (MAPK) pathway mutation(s) within the last 5 years identified by a local test on tumor tissue or blood (eg, rat sarcoma (RAS), rapidly accelerated fibrosarcoma (RAF), and MAPK kinase (MAPKK) mutations).

Disqualifiers

Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.

Part 2: subjects with mixed small-cell lung cancer, or large cell neuroendocrine histology, or sarcomatoid carcinoma.

Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.

Part 1: Uncontrolled or untreated brain metastasis.

Trial design

Design model

Sequential

Treatments tested in this trial

  • D3S-002

    Drug

    Oral Tablet

  • D3S-001

    Drug

    Oral Capsule

Treatment groups

67 Participants
are divided into 2 treatment groups
Group A: D3S-002 MonotherapyExperimental treatment 1 intervention
Group B: D3S-002 and D3S-001 Combination TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants With Adverse Events (AEs)

Time frame
First dose until 30 days after the last dose (or specified in the protocol)
2

Maximum tolerated dose (MTD) based on Dose limiting toxicities (DLTs)

Time frame
First dose up to 24 months
3

Recommended Phase 2 dose (RP2D)

Time frame
First dose up to 24 months

Secondary outcomes

1

Part 1: D3S-002 maximum observed plasma concentration (Cmax)

Time frame
First dose up to 24 months
2

Part 2: D3S-002 and D3S-001 maximum observed plasma concentration (Cmax)

Time frame
First dose up to 24 months
3

Part 1: D3S-002 time to maximum plasma concentration (tmax)

Time frame
First dose up to 24 months
4

Part 2: D3S-002 and D3S-001 time to maximum plasma concentration (tmax)

Time frame
First dose up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

D3 Bio (Wuxi) Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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